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Clinical trial

Collaborative Urological Prosthetics Investigation Directive Research Group

ID
Name
IRB19-1757
Description
The purpose of this study is to determine if an additional 6 days of oral antibiotics decreases the risk of penile prosthesis infection after implantation.
Trial arms
Trial start
2022-04-22
Estimated PCD
2024-12-31
Trial end
2025-01-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Doxycycline
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Arms:
6 days of oral antibiotics
Ciprofloxacin
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Arms:
6 days of oral antibiotics
Augmentin
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Arms:
6 days of oral antibiotics
Bactrim
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Arms:
6 days of oral antibiotics
Size
800
Primary endpoint
Additional 6 days of oral antibiotics after Penile prothesis placement does not decrease the risk of device infection leading to surgical intervention
12 months
Eligibility criteria
Inclusion Criteria: 1. Males aged 35 to 90 yo with no racial or ethnic restrictions and a diagnosis of erectile dysfunction. 2. Males clinically indicated for de-novo InhibiZonetm coated AMS 700 devices IPP placement procedure per local clinical guidelines who have elected to pursue penile prosthesis as an ED treatment. Exclusion Criteria: 1. Patients with indwelling foreign body in the urinary tract \> 24 hours prior to the procedure (i.e. foley catheter). Patients using clean intermittent catheterization will not be excluded. 2. Prior history of or current symptomatic urethral stricture. 3. History of cystitis caused by Tuberculosis. 4. Active Cytoxan/cyclophosphamide therapy or immunosuppressive systemic chemotherapy. 5. Prior augmentation cystoplasty or cystectomy. 6. Systemic neuromuscular disease known to affect the lower urinary tract such as Spinal Cord Injury, Multiple Sclerosis or other condition leading to neurogenic bladder. 7. Antibiotic use within the past 1 week or need for antibiotic management immediately prior to the study. 8. Cases where patients have had a prior penile prosthesis. 9. Any protected population (i.e. Prisoners)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 800, 'type': 'ESTIMATED'}}
Updated at
2024-02-07

1 organization

4 products

2 indications

Organization
University of Chicago
Product
Doxycycline
Indication
Impotence
Indication
Penile Prosthesis Infection
Product
Ciprofloxacin
Product
Augmentin
Product
Bactrim